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Germany: New Law Allows Health Apps by Prescription

(Jan. 30, 2020) On December 19, 2019, the Act to Improve Healthcare Through Digitization and Innovation (Digital Healthcare Act) (English summary) entered into force in Germany. The Digital Healthcare Act allows patients to receive health apps by prescription if certain conditions are met. The Act also makes it easier for patients to make virtual doctor visits and access their health data from anywhere.

Background on the German Health Care System

Health insurance in Germany is compulsory. Everyone whose annual income is below a statutory defined threshold must purchase statutory health insurance (gesetzliche Krankenversicherung, GKV), whereas everyone who earns more than that may instead elect to purchase private insurance (private Krankenversicherung, PKV).

Unemployed persons are also subject to the insurance requirement. Self-employed persons may choose to purchase private insurance instead of statutory health insurance, as they are not subject to the insurance requirement. Even though insurance is compulsory, people who are subject to the insurance requirement may freely choose their insurance company. The selected insurance company must accept the person as a member.

Although all health insurance companies are required by law to offer certain basic services, they may cover additional services. Covered basic services include pregnancy and maternity care, prevention of illnesses, care for aggravated illnesses, birth control, sterilizations, abortions, assessment of health risks and early detection of diseases, treatment of diseases, and medical rehabilitation. The law contains an exhaustive list of permissible additional reimbursable services—for example, midwife services. The Digital Healthcare Act adds digital healthcare apps to the services covered to treat diseases.

Digital Healthcare Apps

The law defines digital healthcare apps as “medical products with a low risk class whose essential function is mainly based on digital technologies, and which are intended to support the detection, treatment, alleviation, or compensation of injuries or disabilities.” Examples mentioned during the parliamentary debate were apps that help people to take their medications on time or to document their blood sugar levels. Insured persons have a legal right to receive reimbursement from their health insurance for digital healthcare apps if the app fulfills the following requirements:

  • The app is included in the register of digital healthcare apps kept by the German Federal Institute for Drugs and Medical Devices (BfArM).
  • The app has been prescribed by a doctor or psychotherapist or has been used with permission of the statutory health insurance.

The list of approved apps is published in the Federal Gazette and available online. In order to be included in the register kept by the BfArM, manufacturers must prove the medical indication of the app. Manufacturers must submit their application electronically and provide evidence

  • of the safety, functionality, and quality of the app;
  • that their product fulfills data protection and data security requirements; and
  • that the app has a positive effect on care.

Positive effects are either medical benefits for the patient or a patient-relevant structural or procedural improvement of care. If a manufacturer cannot yet prove a positive effect, the app may be preliminarily included in the register for up to 12 months. The manufacturer must provide a plausible explanation why the app aids in improving care for patients and submit a scientific evaluation from an independent third-party institution that discusses the positive effects. The required evidence must be submitted during the 12-month period. The trial period may be extended for another 12 months if the submitted evidence is not yet sufficient but the presented trial results indicate the strong likelihood that proof will be possible. If the permanent inclusion in the register is rejected, the BfArM must delete the entry from the register. A new application for inclusion in the register is possible only if new evidence is presented. Manufacturers negotiate the amount of money they will receive for their app directly with the Central Federal Association of Health Insurance Funds.

Virtual Doctor Visits

The Digital Healthcare Act aims to increase the number of virtual doctor visits and make information regarding which doctors offer them more easily accessible. For that purpose, the Digital Healthcare Act allows doctors to advertise those services on their websites.

Other Provisions

The Digital Healthcare Act also includes provisions that require hospitals and pharmacies to connect to the Telematics Infrastructure so that patients may access their electronic patient records from anywhere. Others, such as midwives and physiotherapists, may connect on a voluntary basis and are reimbursed for their costs.

Furthermore, the Digital Healthcare Act recognizes that not all people are equally versed in using digital or telemedical applications. It therefore requires health insurance institutions to offer services that help people acquire the necessary skills.